BI 1291583 for Bronchiectasis

Recruiting at 109 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Augmentation therapy, Antifungal therapy

Disqualifiers: Liver disease, Kidney disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 12 months

269 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term. Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the AirleafTM or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose. Participants visit the study site 10 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific situation with the trial staff or your doctor.

What data supports the effectiveness of the drug BI 1291583 for bronchiectasis?

The research suggests that BI 1291583, a cathepsin C inhibitor, may help reduce airway inflammation and improve symptoms in bronchiectasis by decreasing the activation of certain enzymes that cause lung damage. This is based on the design of a phase 2 trial aiming to evaluate its effectiveness in reducing lung flare-ups and improving patient-reported outcomes. ^{1 2 3 4 5}

Eligibility Criteria

Adults with bronchiectasis who previously participated in the Airleafᵀᴹ study can join this trial. They must consent to the study, be able to use effective birth control methods if applicable, and have completed prior treatment as per protocol. People with certain infections, liver disease, recent vaccinations or infections, or specific medical conditions are excluded.

Inclusion Criteria

I have signed and understand the consent form for this trial.

Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method

I am either male or female.

Exclusion Criteria

You have a positive test for hepatitis B, hepatitis C, or HIV. If these test results change after you join the study, you may not be able to continue participating.

I have been newly diagnosed with extensive warts.

I have been newly diagnosed with a lung condition due to a fungal infection and need treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year

12 months

10 visits (in-person), 4 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 1291583
• Placebo matching BI 1291583

Trial Overview The trial is testing BI 1291583's long-term effects on bronchiectasis symptoms. Participants will take a low, medium, or high dose of BI 1291583 daily for up to a year. Some participants will receive a placebo instead. The study involves nine site visits and four phone calls to monitor health outcomes.

Participant Groups

Group I: BI 1291583 medium dose arm Experimental Treatment 2 Interventions

Group II: BI 1291583 low dose arm Experimental Treatment 2 Interventions

Group III: BI 1291583 high dose arm Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

Bronchiectasis (BE) is a growing global health issue characterized by airway dilation and persistent infections, leading to significant impacts on patients' quality of life, yet treatment guidelines are based on limited high-quality evidence.

Experts identified critical unmet needs in BE management, including the need for better pharmacological treatments to clear airways and reduce inflammation, improved methods for classifying patients, and the establishment of clinical endpoints for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. Flume, PA., Basavaraj, A., Garcia, B., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A Phase 2 randomised study to establish efficacy, safety and dosing of a novel oral cathepsin C inhibitor, BI 1291583, in adults with bronchiectasis: Airleaf. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Benefit-risk assessment of brensocatib for treatment of non-cystic fibrosis bronchiectasis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in bronchiectasis: a propensity-matched study. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Inhaled Corticosteroid Therapy in Bronchiectasis is Associated with All-Cause Mortality: A Prospective Cohort Study. [2023]